Effect of Levosimedan on heart function and pressures during exercise in patients with severe heart failure.

Effect of Levosimedan or Placebo on Exercise Capatity and hemodynamics in Patients with Advanced Chronic Heart Failure (LOCO-CHF trial) - LOCO-CHF trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002049-31-DK

Enrollment

Registered

2017-07-10

Start date

2017-11-30

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced chronic heart failure MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849

Interventions

Trade Name: Simdax Product Name: Simdax Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: LEVOSIMENDAN CAS Number: 141505-33-1 Concentration unit: mg/kg/h mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age =18 years • NYHA III-IV on optimal medical treatment • LVEF =35% • NT-proBNP >600 µg/L • pVO2 =65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: • Recent or acute coronary and respiratory syndromes • Recent sustained ventricular tachycardia or ventricular fibrillation • Severe aortic or mitral valve disease • Known malfunctioning artificial heart valve • Uncorrected obstructive valvular disease • Hypertrophic cardiomyopathy • Fertile women • Uncorrected thyroid disease • Presence of any disease/condition that might per se influence exercise performance • Left ventricular assist device • Pacemaker-guided heart rate at rest or during exercise • Known contraindication for treatment with levosimendan • Any treatment with levosimendan in the previous 6 months • Inability to perform a VO2max test • Symptomatic hypotension or systolic blood pressure < 90 mmHg

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic heart failure.;Secondary Objective: Not applicable;Primary end point(s): •Change in CO/PCWP (?CO/PCWPV1-V3submax) at day 5 (visit 3) after 6 hour infusion of levosimendan (visit 1) at the workload corresponding to 50% of pVO2 determined at baseline (visit 0).;Timepoint(s) of evaluation of this end point: Measure change in the above mentioned parameter at day 5 (visit 3) after 6 hour infusion of levosimendan at randomization (visit 1) at the workload corresponding to 50% of pVO2 determined at baseline (visit 0).	—

Measure

Time frame

Main Objective: To evaluate the subacute effect of levosimendan infusion on exercise capacity and exercise hemodynamics compared with placebo in patients with advanced chronic heart failure.;Secondary Objective: Not applicable;Primary end point(s): •Change in CO/PCWP (?CO/PCWPV1-V3submax) at day 5 (visit 3) after 6 hour infusion of levosimendan (visit 1) at the workload corresponding to 50% of pVO2 determined at baseline (visit 0).;Timepoint(s) of evaluation of this end point: Measure change in the above mentioned parameter at day 5 (visit 3) after 6 hour infusion of levosimendan at randomization (visit 1) at the workload corresponding to 50% of pVO2 determined at baseline (visit 0).

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Secondary

Measure	Time frame
Secondary end point(s): • Change in CO/PCWP (?CO/PCWPV1-V3max) at peak exercise • Change in maximal CO (?COV1-V3) at peak exercise • Change in PCWP (?PCWPV1-V3) at the maximal load obtained during both invasive measurements • Maximal CO, PCWP, SvO2 and workload at visit 3 • Change in resting PCWP, CO, CVP, mPA • Change in 6 MWT at day 3(?6MWTV1-V2), 7 (?6MWTV1-V3) and 14 (?6MWTV1-V4) • Change in NT-proBNP at day 3(?NTproBNPV1-V2), 7 (?NTproBNPV1-V3) and 14 (?NTproBNPV1-V4) • QOL at day 3, 7 and 14.;Timepoint(s) of evaluation of this end point: Measure change in the above mentioned parameters at day 5 (visit 3) after 6 hour infusion of levosimendan at randomization (visit 1) at the workload corresponding to 50% of pVO2 determined at baseline (visit 0).	—

Measure

Time frame

Secondary end point(s): • Change in CO/PCWP (?CO/PCWPV1-V3max) at peak exercise • Change in maximal CO (?COV1-V3) at peak exercise • Change in PCWP (?PCWPV1-V3) at the maximal load obtained during both invasive measurements • Maximal CO, PCWP, SvO2 and workload at visit 3 • Change in resting PCWP, CO, CVP, mPA • Change in 6 MWT at day 3(?6MWTV1-V2), 7 (?6MWTV1-V3) and 14 (?6MWTV1-V4) • Change in NT-proBNP at day 3(?NTproBNPV1-V2), 7 (?NTproBNPV1-V3) and 14 (?NTproBNPV1-V4) • QOL at day 3, 7 and 14.;Timepoint(s) of evaluation of this end point: Measure change in the above mentioned parameters at day 5 (visit 3) after 6 hour infusion of levosimendan at randomization (visit 1) at the workload corresponding to 50% of pVO2 determined at baseline (visit 0).

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Countries

Denmark

Contacts

Public ContactDept. of Cardiology, Rigshospitalet

Heart Center, Department of Cardiology, Rigshospitalet

Finn.Gustafsson@regionh.dk+4535459743

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026